While we all wait for the HREC approval and then trial sites...

While we all wait for the HREC approval and then trial sites and dates to come through, I thought it would be interesting to think about what the immediate implications of this first trial will be. As we all know, the primary endpoint of the trial is safety, but will also provide some preliminary data regarding the effectiveness of the nanoparticles compared to routine biopsy.

· Safety- this is probably the most important factor at the moment. While animal models have been shown to be safe, we are unable to push on with anything further until safety in humans is established. As has been discussed by other posters, it is unlikely that we will have any significant issues regarding safety, however this also can’t be taken as a given. The next major step in further de-risking IBX is to show that the nanoparticles are safe. It should be noted, however, that safety doesn’t mean the complete absence of any side effects. It just means that the side effects should be rare and minimal.

· Effectiveness- alongside safety is the question of effectiveness. We will not have the answer to this questions definitively after this trial, but it will provide some good preliminary data regarding effectiveness and act as a stepping stone to a more comprehensive trial.

Importance of Her2

1. Proof of concept- this is, in my opinion, will be the most important takeaway from the trials. It will show that the nanoparticles work and can be utilised to deliver a real life benefit. As we know, the company has many other plans in the pipeline regarding ovarian cancer, prostate cancer, etc. If we can show that the technology is safe and works for Her2, then the case for IBX

2. Detection of metastatic disease- current treatment paradigms require a biopsy of any concerning lymph nodes using FNA/core biopsy and/or excisional biopsy of the sentinel lymph node at the time of surgery. Being able to use the nanoparticles for the detection of Her2 positive nodal disease is useful, but we should note that this is a small market compared to the overall aims of IBX. That being said, it also represents a significant shift in current imaging methodologies.

3. Detection of residual disease- I haven’t seen the company spruik this line of reasoning much, but it stands to reason that if the technology can be used to detect metastatic disease, then it should also be able to detect residual disease post chemoradiotherapy or surgical excision. This would be a major advance given that current methods of detection of recurrence rely on clinical examination (which is usually next to useless until a nodule has formed), imaging and then biopsy). Naturally, this would require extensive further trials which demonstrate the utility of the nanoparticles for the detection of Her2 disease.

Overall, the future looks very bright. We still have some significant regulatory hurdles to pass before we all start patting ourselves on the back, but it’s hard not to feel positive about progress so far. The future potential for IBX is astronomical (assuming it’s safe and works).